Exporting Bayh Dole to India: Potential Lessons from a Duke Study

In earlier posts analysing the Indian version of the Bayh Dole legislation and its implications (see here and here), we noted as below:

“…the bill also does not give an inventor the discretion to decide whether or not his/her invention is best left in the public domain. Rather, such a discretionary right is only given to the government funding agency (section 5 (3)).

As our readers can appreciate, in some critical areas of science, it may make sense to encourage more “open science” as opposed to a proprietary model.

….Readers may recall an earlier SpicyIP post, where we had spoken about the present CSIR chief, Dr Brahmachari’s laudable move to put the SARS genome in a publicly available database, rather than to patent it. Unfortunately, under the bill, Dr Brahmachari may find that he has no say in the matter anymore and it is the University, and more specifically the “technology transfer office” (TTO) within the University that will be the sole determinant of whether or not the invention ought to be patented.

TTO’s are known to be very aggressive on patents and not very sensitive to alternative ways of achieving technology transfer and knowledge spillovers….

I just came across some very interesting research being conducted at Duke University, as reported in Genome Web. I reproduce some excerpts below:

“How a university tech-transfer office handles its IP-licensing deals “can make a very big difference” in how a genetic test will be used, according to the authors of an ongoing study by researchers at Duke University.

The study is also investigating whether federal agencies that help underwrite the research behind genetic tests can influence their dissemination…

As part of their study, the researchers analyzed 93 patents that are the basis for a suite of DNA-based diagnostics offered by reference laboratory Athena Diagnostics. The patents cover part of the more than 240 individual genetic tests the lab performs for a wide variety of specific conditions across approximately 30 diseases categories.

The Duke researchers analyzed each of the patents to assess what the specific claims were; who the original assignees of the patents were (i.e., whether Athena in-licensed the patents from non-profit research institutes or other companies); and whether the patents disclosed federal support for the research leading to the patented invention.

They found that of the 93 patents granted to a total of 101 different assignees, Athena Diagnostics was the sole assignee of just seven, meaning that most of the IP covering the lab’s genetic tests has been in-licensed from other entities.

Further analysis revealed that over 75 percent of the licensed patents were originally assigned to non-profit entities worldwide. About half of the 101 patent assignees are US-based non-profits, including 41 US-based universities and 14 US-based non-profit research institutes. The remaining assignees included US or international corporations or individuals, including the seven assigned to Athena.

According to the study’s authors, one concern is that widespread access to gene-based diagnostics might be limited due to one company aggregating all of the IP surrounding the test.

Athena, for one, has been criticized in the past for enforcing its patents against infringers at other companies, universities, and hospitals. One well-publicized case in the late 1990s involved an Alzheimer’s gene test that Athena non-exclusively licensed from Duke and, according to critics, prevented others from using on even a research level.”

In all fairness, the study notes that “even when companies keep a tight grip on university-developed patents for genetic tests, it does not always have a negative impact.” Rather this study hints that this might need to be assessed on a case by case basis.

Shamnad Basheer

Shamnad Basheer

Prof. (Dr.) Shamnad Basheer founded SpicyIP in 2005. He's also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof. Amartya Sen. Professional History: After graduating from the NLS, Bangalore Prof. Basheer joined Anand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Later, he was the Honorary Research Chair of IP Law at Nirma University and also a visiting professor of law at the National Law School (NLS), Bangalore. Prof. Basheer has published widely and his articles have won awards, including those instituted by ATRIP, the Stanford Technology Law Review and CREATe. He was consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also served on several government committees.

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